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    K Number
    K180820
    Device Name
    Tono Vue Non-Contact Tonometer
    Manufacturer
    Crystalvue Medical Corporation
    Date Cleared
    2018-12-14

    (260 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K111710
    Why did this record match?
    Device Name :

    Tono Vue Non-Contact Tonometer

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human eye in vivo.

    The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.

    Device Description

    TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.

    AI/ML Overview

    The provided text describes the acceptance criteria and a clinical study conducted for the TonoVue Non-Contact Tonometer.

    Here's an analysis of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    No more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance ±5mmHg. (Based on ISO 8612:2009 Ophthalmic instruments-tonometers)The test result of the TonoVue non-contact tonometer is met the requirement of ISO 8612:2009: "No more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance ±5mmHg."

    Additional performance claims:

    • Accuracy and Reproducibility: Bench testing proved that the TonoVue non-contact tonometer's IOP measurement result meets product specifications.
    • Electrical Safety & EMC: Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).
    • Biocompatibility: Complies with ISO 10993-1 standard.
    • Software Validation: Software verification and validation testing were conducted as recommended by FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

    2. Sample size used for the test set and the data provenance

    • Sample Size: 120 patients.
    • Data Provenance: The text does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a clinical testing section and refers to "patients," it's implicitly a prospective clinical study.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    The document does not specify the number of experts or their qualifications for establishing ground truth, nor does it explicitly mention "experts" in the context of ground truth for the clinical study. It refers to a "reference tonometer reading," which would imply an accepted standard for measuring IOP.

    4. Adjudication method for the test set

    The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The criteria focus on the agreement between the test tonometer and a "reference tonometer."

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The device is a standalone non-contact tonometer, not an AI-assisted diagnostic tool for human readers.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Yes, the clinical testing describes the standalone performance of the TonoVue Non-Contact Tonometer, comparing its readings to a "reference tonometer." This is an algorithm-only performance assessment in measuring IOP.

    7. The type of ground truth used

    The ground truth was established by readings from a "reference tonometer" as per the ISO 8612:2009 standard. This implies a standard, accepted method for measuring intraocular pressure.

    8. The sample size for the training set

    The document does not mention a "training set" or any machine learning/AI components that would require one. The validation described is for a medical device that mechanically measures IOP.

    9. How the ground truth for the training set was established

    Not applicable, as no training set for a machine learning model is mentioned.

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